FDA Drug recall D-0010-2023
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408
- FDA Drug
- Class II
- completed
- Published 2022-10-26
On 2022-10-26 the FDA classified a Class II recall of Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 by Ingenus Pharmaceuticals, citing out of specification for related substances (impurities).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0010-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-09-30 |
| Published | 2022-10-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Ingenus Pharmaceuticals |
| Distribution | US |
Product
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
Reason
Out of specification for related substances (impurities).
Identifiers
| upc | 350742317257 |
|---|---|
| ndc | 50742-317-25 |
| code_info | Lot #: 22E040 Exp. 07/2023; 22F038 Exp. 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0010-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.